EP0551465B1 - Dipositif d'acces d'un flacon sans aiguille - Google Patents

Dipositif d'acces d'un flacon sans aiguille Download PDF

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Publication number
EP0551465B1
EP0551465B1 EP19920915904 EP92915904A EP0551465B1 EP 0551465 B1 EP0551465 B1 EP 0551465B1 EP 19920915904 EP19920915904 EP 19920915904 EP 92915904 A EP92915904 A EP 92915904A EP 0551465 B1 EP0551465 B1 EP 0551465B1
Authority
EP
European Patent Office
Prior art keywords
cannula
stopper
tip
cannula assembly
shaft
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
EP19920915904
Other languages
German (de)
English (en)
Other versions
EP0551465A1 (fr
Inventor
Thomas E. Dudar
Peter L. Graham
Steven C. Jepson
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Baxter International Inc
Original Assignee
Baxter International Inc
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Baxter International Inc filed Critical Baxter International Inc
Publication of EP0551465A1 publication Critical patent/EP0551465A1/fr
Application granted granted Critical
Publication of EP0551465B1 publication Critical patent/EP0551465B1/fr
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2096—Combination of a vial and a syringe for transferring or mixing their contents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/02—Access sites
    • A61M39/04—Access sites having pierceable self-sealing members
    • A61M39/045—Access sites having pierceable self-sealing members pre-slit to be pierced by blunt instrument
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M39/14—Tube connectors; Tube couplings for connecting tubes having sealed ends
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/162—Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/1406—Septums, pierceable membranes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J2200/00—General characteristics or adaptations
    • A61J2200/10—Coring prevention means, e.g. for plug or septum piecing members
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M2005/3201—Coaxially assembled needle cannulas placed on top of another, e.g. needles having different diameters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M39/00—Tubes, tube connectors, tube couplings, valves, access sites or the like, specially adapted for medical use
    • A61M39/10—Tube connectors; Tube couplings
    • A61M2039/1072—Tube connectors; Tube couplings with a septum present in the connector
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/19—Constructional features of carpules, syringes or blisters
    • A61M2205/192—Avoiding coring, e.g. preventing formation of particles during puncture
    • A61M2205/195—Avoiding coring, e.g. preventing formation of particles during puncture by the needle tip shape
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/19—Constructional features of carpules, syringes or blisters
    • A61M2205/192—Avoiding coring, e.g. preventing formation of particles during puncture
    • A61M2205/197—Avoiding coring, e.g. preventing formation of particles during puncture by the seal material

Definitions

  • the invention generally pertains to coupling systems usable to transfer materials from one flow conduit to another. More particularly, the invention pertains to two-part coupling members with a first part including a pre-slit septum and a second part including a blunt cannula. The pre-slit septum slidable receives the blunt cannula to effect the coupling.
  • the systems have particular applicability in the medical field for handling medications and body fluids.
  • the present invention relates generally to a structure for piercing a barrier and placing both sides of the barrier in fluid communication. More particularly, the present invention relates to a cannula assembly adapted for use with stoppers used as closures in drug vials.
  • injection sites usable with pointed cannulae have long been known.
  • such sites can be formed with a housing having a fluid flow path therein.
  • a septum is positioned in the housing closing the fluid flow path.
  • a pointed cannula can be forced through the septum into fluid flow communication with the flow path in the site housing.
  • Known injection sites usable with a piercing cannula can be physically damaged by repetitive piercing caused by the sharp cannula. This damage, known as coring or laceration, can result in subsequent leakage.
  • a large number of drugs are packaged in well known glass or plastic drug bottles or vials having rubber-like stoppers. Similar to injection sites, the stoppers on the drug vials are pierceable by a needle or cannula having a sharpened tip when secured to a syringe assembly of a well-known construction. Typically, the needle is brought to a point on one side of the needle wall by a bevel structure so that the needle tip is quite sharp. Drug vials are also subject to coring by such needles. Particulate matter can subsequently be generated and injected into the patient or otherwise contaminate the content of the vial.
  • dispensing pins can be used to penetrate the stopper of drug vials.
  • Such dispensing pins are typically a sharp spike cannula and can employ a check valve in an effort to prevent gross fluid leakage.
  • a standard luer fitment typically closed off, when not in use, by a cap.
  • GB-A-843744 discloses a catheter tube having a blunt end and carrying a pointed, hollow needle at that end. The needle is used to advance the catheter through the skin into a vessel and the needle can then be withdrawn relative to the catheter. There is no disclosure of a device for penetrating a closure, such as a stopper of a vial.
  • the preferred embodiment of the invention includes a blunt cannula and a piercing member including a tip having a sharpened or spike point capable of piercing an unslit stopper or closure, a shaft extending from the tip and a means to release the piercing member from the cannula while preventing inadvertent disengagement of the piercing member and the cannula.
  • Attached to a receiver, such as a standard syringe the cannula assembly is inserted through a vial stopper and into the vial so that the vial fluid can be infused into the receiver. After infusion, the cannula assembly is withdrawn from the vial with the piercing member being contained within and disposed with the vial. Used in this manner, the cannula assembly allows the medical professional to access a standard drug vial with minimal exposure to a sharpened piercing member and is left with a blunt cannula to conclude the drug administration procedure to a patient.
  • the preferred embodiment of the piercing member 12 of the present invention is illustrated in Figure 1 and as part of the cannula assembly 10 of the present invention, in Figure 2.
  • the piercing member 12 includes a tip 14, a shaft 16 and a retention means.
  • tip 14 has a sharpened or spike point 18, a body portion 20 and a base 22.
  • Body portion 20 is provided with at least one cutout, preferably two cutouts 24 and 26.
  • the shaft 16 has a squared off portion 28 fitting within cutouts 24, 26 so that shaft 16 is integrally connected with and extending from tip 14.
  • At least one channel, preferably two channels 30 and 32, are created by the fitment of squared portion 28 and cutouts 24, 26.
  • the shaft 16 terminates at the opposing end in a taper surface 34.
  • Opposing taper surface 34, retention means in the preferred embodiment includes a detent 36.
  • the preferred embodiment shown in Figure 1 also includes an alignment means which is a series of corners 38, 40, 42, and 44 positioned at the termination of squared portion 28. From corners 38, 40, 42 and 44 the shaft conforms or transits in region 46 from the generally squared portion 28 into a generally cylindrical extension 48.
  • the cannula assembly 10 illustrated in Figure 2 is designated generally by the reference numeral 10 and includes a blunt cannula 50 and piercing member 12.
  • the cannula 50 includes a proximal end 52 defining an interior region 54 and may have a luer flange 56 for connection to a suitable mating engaging structure such as a syringe.
  • a generally cylindrical mid-region 58 extends from the proximal end 52 and an end region 60 extends from the mid-region 58.
  • This embodiment of the cannula 50 minimizes kick-back or recoil owing to the provisions of substantially cylindrical mid-region 58.
  • This embodiment of the cannula 50 also increases withdrawal or tug resistance.
  • a generally cylindrical internal flow channel 62 extends through the end region 60 and mid-region 58 in communication with the interior region 54 of the proximal end region 52.
  • the end region 60 is provided with a tapered surface 66 to minimize the insertion force.
  • the shaft 16 of piercing member 12 is slidably received within flow channel 62 of blunt cannula 50 through end region 60.
  • shaft 16 When completely received within cannula 50, shaft 16 extends into interior region 54 of cannula 50 and base 22 contacts the distal blunt end 68 of end region 60.
  • the detent 36 is positioned against the stepped wall 70 between proximal end 52 and mid-region 58 to prevent the inadvertent disengagement of piercing member 12 and cannula 50. Corners 38, 40, 42 and 44 align or center piercing member 12 within flow channel 62.
  • a void 72 is created between shaft 16 and interior surfaces of end region 60 and mid-region 58. Void 72 permits fluid and air flow through flow channel 62 despite the presence of shaft 16.
  • cannula assembly 10 can be packaged as a single-use medical device in a sterile blister pack and utilize a standard tip protector cover over cannula assembly 10.
  • cannula assembly 10 is removed from the blister pack and releasably connected to a fluid flow member or receiver such as a syringe 74 of known construction.
  • a fluid flow member or receiver such as a syringe 74 of known construction.
  • a standard single use drug vial 76 having a solid closure or stopper 78 is prepared.
  • a volume of air can be drawn into or expelled from syringe 74, if required, without dislodging cannula assembly 10.
  • tip 14 can be lubricated, for example, during the manufacturing process, with silicone.
  • cannula assembly 10 is inserted through stopper 78 until stepped wall 70 provides a positive stop to insertion by meeting the upper surface of either vial 76 and/or stopper 78.
  • Complete insertion is achieved when tip 14 and the immediate portion of shaft 16 pass beyond stopper 78 and enter the vial chamber 80.
  • the liquid held in vial chamber 80 can now be removed through cannula assembly 10 and into the syringe 74.
  • syringe 74 and cannula assembly 10 are withdrawn from vial 76.
  • base 22 of tip 14 meets stopper 78 and prohibits the further withdrawal of piercing member 12.
  • sufficient force is created to cause taper surface 34 to deflect, permitting detent 36 to slide over stepped wall 70 and through flow channel 62, thereby permitting the disengagement of piercing member 12 from cannula 50.
  • cannula 50 while still connected with syringe 74, is completely withdrawn from stopper 78.
  • Piercing member 12 remains either in the vial chamber 80 or imbedded in stopper 78.
  • the vial 76 with piercing member 12 can then be disposed of without the user having any further exposure to spike point 18 or piercing member 12.
  • the syringe 74 with cannula 50 is now ready for insertion into an injection site or other closure having a pre-slit septum, for example as those disclosed in related pending applications.
  • retention means of the preferred embodiment of the cannula assembly 10 has been described as a force fit between detent 36 and stepped wall 70, retention could be achieved when detent 36 remains in flow channel 62 of mid-region 58 causing the end of shaft 16 to flex and contact at least some portion of the inner surface or wall of mid-region 58. Retention could also be achieved through a spring-type action. Absent detent 36, a spring action retention means can be achieved through a naturally arced or curved shaped shaft with sufficient flexibility so that the shaft generally straightens upon insertion into flow channel of the cannula. When the base of tip contacts the vial stopper and causes the separation of the piercing member from the cannula, the shaft returns to its natural curved state.
  • piercing member 90 includes a solid tip 92 with a pair of stand-offs 94 and 96 positioned on the base 98 of tip 92. Upon assembly of cannula 50 and piercing member 90, stand-offs 94, 96 rest against distal blunt end 68 of cannula 50. Stand-offs 94, 96 create a void 100 to permit fluid and air flow through the flow channel 62 of cannula 50.
  • piercing member 90 is provided with a retention means including a detent 102 differing from the preferred detent 36 in shape. Detent 102 cooperates with a stepped portion 104 of the terminal end of shaft 106 in the appropriate retention through either force fit or a spring action, of piercing member 90 within cannula 50.
  • Figure 5 illustrates a third embodiment of piercing member 110 differing in tip 112 being of a general arrowhead structure and shaft 114 although generally cylindrical in shape also having an outer diameter gradually decreasing through shaft 114 from the integral connection with tip 112 to the terminal end 116 of shaft 114.
  • piercing member 110 is force fit into flow channel 62 of cannula 50.
  • the piercing member 110 will remain either in the vial chamber 80 or imbedded in stopper 78 upon withdrawal of cannula 50 as the base 118 of the arrowhead tip 112 does not permit withdrawal from stopper 78.
  • the force fit of piercing member 110 can also be achieved by reversing the variation of the outer diameter, that is increasing from integral connection with tip 112 to terminal end 116 of shaft 114.
  • the force fit retention is achieved as long as interference occurs at some point along the shaft and the inner surface of cannula.
  • Figure 6 also illustrates another embodiment of piercing member 120 differing in a solid tip 122 integrally connected with the shaft 124 at a thickened neck portion 126 of shaft 124.
  • the neck portion 126 is of a sufficient thickness so as to provide a void 128 between distal blunt end 68 and tip 122.
  • a groove 130 is formed to permit fluid flow along shaft 124.
  • the subject piercing member 120 is provided with a pair of deflecting fingers 132, 134 which can be forcibly flexed inward or toward one another upon assembly of piercing member 120 and cannula 50.
  • deflecting fingers 132, 134 Upon insertion in flow channel 62, deflecting fingers 132, 134 will naturally flex outwardly once they pass stepped wall 70 of cannula 50, thereby functioning similarly to tapered surface 34 and detent 36. Further, if deflecting fingers 132, 134 do not pass stepped wall 70, but remain in flow channel 62, deflecting fingers 132, 134 will achieve retention of piercing member 120 in cannula 50 through a spring action.
  • the cannula assembly 140 shown in Figure 7 includes a piercing member 142 having a tip 144 of an arrowhead shape which is friction fit over distal blunt end 68 of cannula 50 as opposed to a force fit or spring action retention within flow channel of cannula.
  • piercing member 142 parts from cannula 50 and remains in the drug vial chamber 80.
  • piercing member 142 could be provided with a plurality of flexible fingers, creating an umbrella-type structure. Due to their flexibility, upon insertion of such a cannula assembly into a drug vial stopper, the fingers would fold in or close as an umbrella-type structure and then relax in a partially opened state after complete insertion. Upon withdrawal of such an assembly, the flexible fingers would contact the underside of the stopper and fan out, causing the separation of the piercing member from the cannula, thereby prohibiting the removal of such a piercing member from the vial.

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  • Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Pulmonology (AREA)
  • Vascular Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Thin Film Transistor (AREA)
  • Magnetic Resonance Imaging Apparatus (AREA)
  • Catalysts (AREA)
  • Sampling And Sample Adjustment (AREA)
  • Surgical Instruments (AREA)
  • Telephone Function (AREA)
  • Medicinal Preparation (AREA)
  • Physical Or Chemical Processes And Apparatus (AREA)
  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
  • Dowels (AREA)

Claims (21)

  1. Dispositif de canule comprenant une canule émoussée (50),ayant une extrémité proximale (52) avec une région intérieure (54) et se terminant par un moyen (56) de connexion à une structure d'accouplement appropriée, une région intermédiaire sensiblement cylindrique (58) s'étendant à partir de l'extrémité proximale, une région d'extrémité (60) s'étendant à partir de la région intermédiaire et se terminant par une extrémité distale émoussée (68) et présentant une surface extérieure conique (66), et un canal d'écoulement intérieur (62) s'étendant dans la région d'extrémité et la région intermédiaire pour communiquer avec l'espace intérieur de la région d'extrémité proximale,
    caractérisé par :
       un élément de perçage (12;90;110;120;142) comportant des moyens de retenue (16,36;106,102;114;124,132, 134) qui retiennent de façon libérable l'élément de perçage sur la canule émoussée, et comportant un bout de perçage (14;92;112;122;144) situé à l'extrémité distale émoussée (68) pour percer un obturateur plein ou un bouchon afin de permettre le passage de l'extrémité distale émoussée à travers l'obturateur ou le bouchon percé,
       l'élément de perçage comprenant une partie (22; 98;118;128) qui peut venir en prise avec l'obturateur ou le bouchon lors du retrait de la canule émoussée, de façon à provoquer la libération des moyens de retenue par rapport à la canule émoussée et la retenue de l'élément de perçage par l'obturateur ou le bouchon.
  2. Dispositif de canule suivant la revendication 1, dans lequel le bout (14;92;122) comprend une pointe (18), un corps (20) et une base (22,98).
  3. Dispositif de canule suivant la revendication 2, comprenant au moins un canal (30,32) qui s'étend longitudinalement dans la partie de corps (20) ou longitudinalement le long de cette partie.
  4. Dispositif de canule suivant la revendication 2 ou 3, comprenant une tige (16,106,124) solidaire de la base (22,98) du bout (14,92,122) et s'étendant à partir de cette base.
  5. Dispositif de canule suivant la revendication 2,3 ou 4, dans lequel la partie de corps (20) du bout présente une forme sensiblement conique.
  6. Dispositif de canule suivant une quelconque des revendications 2 à 5, dans lequel le bout (92) comprend des moyens d'alignement comportant au moins un élément en relief (94,96) solidaire de la base (98).
  7. Dispositif de canule suivant une quelconque des revendications 2 à 5, dans lequel la tige (16) comprend des moyens d'alignement ayant une partie de section carrée (28) solidaire du bout (14) et qui présente une série d'angles (38,40,42,44), à l'opposé du bout, qui débutent une région de transition formant une extension sensiblement cylindrique (48).
  8. Dispositif de canule suivant une quelconque des revendications 2 à 5, dans lequel la tige (124) comprend des moyens d'alignement comportant une collerette épaissie (126) solidaire de la base du bout (122).
  9. Dispositif de canule suivant une quelconque des revendications 2 à 6,dans lequel la tige (124) comporte un évidement (130) pour permettre l'écoulement de fluide ou d'air dans le canal d'écoulement (62).
  10. Dispositif de canule suivant une quelconque des revendications 2 à 6, dans lequel un vide (72, 128) est créé entre la tige (16) et la canule (50) du fait que la tige présente un diamètre extérieur plus petit que le diamètre intérieur du canal d'écoulement (62).
  11. Dispositif de canule suivant la revendication 1, dans lequel les moyens de retenue comprennent un ajustement à friction avec l'extrémité distale émoussée (60) de la canule émoussée .
  12. Dispositif de canule suivant la revendication 1, dans lequel les moyens de retenue comprennent un diamètre extérieur variable de la tige (114) de sorte qu'un contact à interférence est créé à un certain point entre la tige et une surface intérieure de la canule émoussée (50).
  13. Dispositif de canule suivant une quelconque des revendications 1 à 10, dans lequel les moyens de retenue comprennent un diamètre extérieur progressivement décroissant de la tige (114) à partir du bout (112), ou une surface biseautée d'une extrémité terminale de la tige (16) à l'opposé du bout (14) et une saillie d'enclenchement (36) solidaire de l'extrémité terminale et en face de la surface biseautée, ou une surface épaulée (104) sur une extrémité terminale de la tige (106) à l'opposé du bout et une saillie d'enclenchement (102) solidaire de l'extrémité terminale et en face de la surface épaulée.
  14. Dispositif de canule suivant une quelconque des revendications 1 à 10, dans lequel les moyens de retenue comprennent deux doigts flexibles (132,134) qui peuvent être flechis de force vers l'intérieur par coopération de l'élément de perçage avec le canal d'écoulement (62).
  15. Dispositif de canule suivant une quelconque des revendications précédentes, dans lequel l'élément de perçage comprend un bout (14;92;122;144) ayant une structure en pointe de flèche, une structure en parapluie ou une pluralité de doigts flexibles.
  16. Dispositif de canule comprenant une canule émoussée (50) avec une extrémité distale émoussée (68), une extrémité proximale (52) et une région intermédiaire (58) qui relie les extrémités distale et proximale, un épaulement (70) séparant la région intermédiaire et l'extrémité proximale , une région intérieure dans toute la région intermédiaire et se terminant à chaque extrémité de façon à définir un canal d'écoulement (62), et un élément de perçage (12) comprenant :
       un bout (14) qui comporte une pointe (18), un corps sensiblement conique (20) et une base (22) avec au moins une entaille (24,26) à travers le corps et la base,
       une tige (16) qui comporte une partie de section carrée (28) solidaire de la base (22) du bout et s'étendant à partir de celle-ci et se terminant dans une série d'angles (38,40,42,44), une région de transition (46) convergeant à partir des angles vers un prolongement sensiblement cylindrique (48) jusqu'à une extrémité proximale, les angles étant en contact avec l'extrémité distale de la canule,
       la tige étant reçue dans le canal d'écoulement (62) de sorte que le bout (14) est situé à l'extrémité distale émoussée (68) de la canule (50) pour percer un obturateur plein ou un bouchon afin de permettre le passage de l'extrémité distale émoussée (68) à travers l'obturateur ou le bouchon percé,
       des moyens de retenue (36) sur la tige (16) qui coopèrent avec l'épaulement (70) pour retenir l'élément de perçage (12) de façon libérable dans la canule émoussée (50),
       la base (22) pouvant venir en prise avec l'obturateur ou le bouchon lors du retrait de la canule émoussée, de façon à provoquer la libération des moyens de retenue (36) par rapport à la canule émoussée et la retenue de l'élément de perçage par l'obturateur ou le bouchon.
  17. Dispositif de canule suivant la revendication 16, dans lequel les moyens de retenue comprennent une saillie d'enclenchement (36) solidaire de l'extrémité proximale de la tige (16).
  18. Procédé d'exécution d'un transfert de fluide d'un flacon de médicament comportant un bouchon plein à un récepteur au moyen d'un dispositif de canule suivant la revendication 1, comprenant les étapes de :
       connexion libérable du dispositif de canule au récepteur ;
       positionnement du dispositif de canule connecté, au centre du bouchon,et application d'une force pour l'insertion de l'élément de perçage (12;90,110, 120;142) dans et à travers le bouchon ;
       transfert du fluide du flacon de médicament au récepteur par l'intermédiaire du dispositif de canule; et
       extraction de la canule (120) hors du bouchon de sorte que l'élément de perçage rencontre le bouchon et se dégage de la canule et soit retenu dans le flacon.
  19. Procédé suivant la revendication 18, comprenant l'étape d'aspiration d'un volume d'air dans le récepteur après connexion du dispositif de canule au récepteur sans dissocier le dispositif du récepteur.
  20. Procédé suivant la revendication 18, comprenant l'étape d'expulsion d'un volume d'air du récepteur dans le flacon de médicament après insertion de l'élément de perçage à travers le bouchon, sans dissocier le dispositif de canule du récepteur.
  21. Procédé suivant la revendication 18, dans lequel l'élément de perçage dégagé est emprisonné dans le bouchon.
EP19920915904 1991-07-30 1992-07-09 Dipositif d'acces d'un flacon sans aiguille Expired - Lifetime EP0551465B1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US07/737,735 US5411499A (en) 1988-01-25 1991-07-30 Needleless vial access device
US737735 1991-07-30
PCT/US1992/005752 WO1993002724A1 (fr) 1991-07-30 1992-07-09 Dipositif d'acces d'un flacon sans aiguille

Publications (2)

Publication Number Publication Date
EP0551465A1 EP0551465A1 (fr) 1993-07-21
EP0551465B1 true EP0551465B1 (fr) 1996-02-21

Family

ID=24965099

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19920915904 Expired - Lifetime EP0551465B1 (fr) 1991-07-30 1992-07-09 Dipositif d'acces d'un flacon sans aiguille

Country Status (13)

Country Link
US (1) US5411499A (fr)
EP (1) EP0551465B1 (fr)
JP (1) JP3303095B2 (fr)
AT (1) ATE134312T1 (fr)
AU (2) AU653630B2 (fr)
BR (1) BR9205463A (fr)
CA (1) CA2092832C (fr)
DE (1) DE69208448T2 (fr)
DK (1) DK0551465T3 (fr)
ES (1) ES2086758T3 (fr)
IE (1) IE73876B1 (fr)
MX (1) MX9204206A (fr)
WO (1) WO1993002724A1 (fr)

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Also Published As

Publication number Publication date
JP3303095B2 (ja) 2002-07-15
DE69208448T2 (de) 1996-07-11
IE73876B1 (en) 1997-07-02
EP0551465A1 (fr) 1993-07-21
JPH06502578A (ja) 1994-03-24
CA2092832A1 (fr) 1993-01-31
DK0551465T3 (da) 1996-03-18
AU6884394A (en) 1994-09-29
ATE134312T1 (de) 1996-03-15
CA2092832C (fr) 2002-03-05
US5411499A (en) 1995-05-02
IE922201A1 (en) 1993-02-10
AU653630B2 (en) 1994-10-06
AU2337792A (en) 1993-03-02
ES2086758T3 (es) 1996-07-01
BR9205463A (pt) 1994-03-01
DE69208448D1 (de) 1996-03-28
MX9204206A (es) 1993-04-01
WO1993002724A1 (fr) 1993-02-18

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